JB Chemicals Gets Go-Ahead to Sell Antidepressant in the US

Image Source: Medical Dialogues

JB Chemicals and Pharmaceuticals Ltd has received approval from the US Food and Drug Administration (US FDA) for its abbreviated new drug application (ANDA) for Amitriptyline Hydrochloride Tablets. This approval allows the company to market its generic version of the antidepressant in the United States, further strengthening its international presence.

Key Highlights:

The US FDA has approved JB Chemicals’ Amitriptyline Hydrochloride Tablets in six dosage strengths: 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg.
Amitriptyline Hydrochloride is a tricyclic antidepressant widely prescribed for managing major depressive disorders and for the relief of depression symptoms.
This approval enables JB Chemicals to introduce its generic formulation in the US market, a significant step in expanding its regulated market portfolio.
The US is a key focus area for JB Chemicals, and this approval is expected to support the company’s long-term growth in international markets.

The company has been investing in a diversified pipeline and contract development and manufacturing operations, which has helped drive its recent financial performance.

In the quarter ending March 2025, JB Chemicals reported a 15.5% year-on-year rise in net profit to ₹145.7 crore, with revenues up 10.2% to ₹949.5 crore.

The company’s shares saw positive movement following the announcement, reflecting investor confidence in its global expansion strategy.

Source: Business Standard, Indian Pharma Post, Moneycontrol, CNBC-TV18, EquityBulls